Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products

NCT ID: NCT04846270

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2021-10-28

Brief Summary

The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.

Detailed Description

The TENA SmartCare Change Indicator is intended for use on individuals, dependent end user (DEU), suffering from Urinary Incontinence (UI) who are cared for in a home environment, by one or more caregivers (CGR). The TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to reduce the number of manual checks between daily changes of absorbing incontinence products. Secondarily, the investigation will evaluate number of leakages, skin redness, usability and fecal incidence. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Investigational Device

TENA SmartCare Change Indicator

Group Type: EXPERIMENTAL

TENA SmartCare Change Indicator

Intervention Type: DEVICE

Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable.

Interventions

TENA SmartCare Change Indicator

Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.

2. DEU is unable to sufficiently communicate the need for an incontinence product to be changed.

3. DEU is being cared for in a home environment and most of the care is provided by a main CGR.

4. DEU is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the DEU. Note, the legally designated representative and main CGR cannot be the same person.

5. CGR is willing and able to provide informed consent to participate in the clinical investigation.

6. The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process.

7. If incontinence is managed by pharmaceuticals, the dose regime is stable.

8. DEU and CGR ≥ 18 years of age.

Exclusion Criteria

1. DEU is cared for in a professional establishment or is institutionalized.

2. DEU has ≥ 4 fecal "incidences" per week.

3. DEU has severe incontinence product related skin problems, as judged by the investigator.

4. DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.

5. The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.

6. Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.

7. CGR is incapable or unwilling to use the required smart phone application and/or the diary registration webpage required for the clinical investigation.

8. Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation.

9. DEU is pregnant or nursing.

10. CGR or DEU with an alcohol or drug addiction

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essity Hygiene and Health AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Piotr Radziszewski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa,

Locations

Medical Concierge Centrum Medyczne

Warsaw, , Poland

Countries

Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

POWER

Identifier Type: -

Identifier Source: org_study_id